The following data is part of a premarket notification filed by Rita Medical Systems with the FDA for Mr Compatible Rita Model 90 Electosurgical Accessory.
Device ID | K023846 |
510k Number | K023846 |
Device Name: | MR COMPATIBLE RITA MODEL 90 ELECTOSURGICAL ACCESSORY |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | RITA MEDICAL SYSTEMS 967 NORTH SHORELINE BLVD. Mountain View, CA 94043 |
Contact | Karen Frischmeyer |
Correspondent | Karen Frischmeyer RITA MEDICAL SYSTEMS 967 NORTH SHORELINE BLVD. Mountain View, CA 94043 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-11-19 |
Decision Date | 2002-12-06 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H7877001039071 | K023846 | 000 |
H7877001039061 | K023846 | 000 |
H7877001024411 | K023846 | 000 |
H7877001024211 | K023846 | 000 |